Use of CPETarm for Risk Stratification of Patients With CLTI

NCT06404229 | Not Yet Recruiting

• 1 other identifier: 329960
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective cohort study of patients undergoing surgery for chronic limb threatening ischaemia. Prior to surgery, patients will undergo CardioPulmonary Exercise testing (CPET) using an arm ergometer. Feasibility outcome measures will be recorded at testing and participants will be followed up for a period of up to 5 years to obtain clinical outcome measures.

Conditions

Chronic Limb-Threatening Ischemia; Surgery-Complications

Keywords

CardioPulmonary Exercise Testing; Risk Stratification

Outcome Measures

Primary Outcomes (5)

• Acceptability of bedside CPET

  The percentage of recruited participants actually performing CPET compared to the number of patients consenting. (A) identifying reasons, and their number, as to why participants did not undertake CPET, and (B) identifying reasons, and their number, for clinician-led termination of CPET

  At time of CPET testing (1 day)

• Recruitment rate (uptake of bedside CPET)

  The percentage of eligible patients who gave informed consent to participate in the study

  At time of CPET testing (1 day)

• Practicality of bedside CPET

  Recorded as three variables 1. Time between decision for surgical intervention and CPET testing 2. Location of testing 3. Duration of testing (inclusive of set up, patient instructions, completion of test and recovery)

  At time of CPET testing (1 day)

• Patient reported outcome measures

  Established by identifying participant opinions on satisfaction with, and suitability of, CPET for future use. Assessed in a qualitative manner using a semi structured interview with 8 pre determined questions and quantitatively using a 5 point Likert scale for 12 statements, whereby 1='strongly disagree' and 5='strongly agree'.

  30 days

• Adverse or unexpected events report

  Defined as participants experiencing serious adverse events during or after the test. Defined adverse events for CPET as: 1) death during the stress test, 2) external defibrillation or implantable cardioverter-defibrillator discharge, 3) sustained ventricular tachycardia (wide complex tachycardia lasting longer than 30 seconds), 4) myocardial infarction, 5) syncope, 6) administration of advanced cardiac life support medications, 7) referral for direct hospital admission, or 8) referral to emergency department

  At time of CPET testing (1 day)

Secondary Outcomes (11)

• Peri-operative complications

  Recorded at 30 days

• All cause mortality

  Recorded at 30 days, 90 days, 1 year, 3 years and 5 years

• Amputation-free survival

  Recorded at 30 days, 90 days, 1 year, 3 years and 5 years

• Level of care post-surgery

  Recorded at 30 days

• Higher level of care length of stay

  Recorded at 30 days

Study Arms (1)

CardioPulmonary Exercise Testing

EXPERIMENTAL

All patients included in the study will perform CardioPulmonary Exercise Testing prior to surgery

Diagnostic Test: CardioPulmonary Exercise Testing

Interventions

CardioPulmonary Exercise Testing DIAGNOSTIC_TEST

CardioPulmonary Exercise Testing using an arm ergometer prior to surgery

CardioPulmonary Exercise Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability and willingness to give written informed consent
• Diagnosis of chronic limb threatening ischaemia, undergoing one of the following procedures: Infra inguinal bypass, Extra anatomical bypass, Common femoral endarterectomy, Endovascular treatment, Primary amputation

You may not qualify if:

• Patients with active medical conditions deemed an absolute contraindication for undertaking CPET
• Ongoing evaluation for coronary artery disease (e.g awaiting stress test or cardiac catheterisation or requiring the up titration of anti anginal medications)
• Active arrthymic requiring the initiation or up titration of an anti arrthymic medication
• Active congestive cardiac failure requiring the initiation or up titration of diuretic therapy.
• Severe cardiac valvular stenosis
• Physical disability precluding ability to perform CPETarm
• Psychiatric disorder or dementia precluding them from consenting for research and/or undertaking testing and/or follow up

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

University of Manchester

Manchester, Greater Manchester, M13 9PL, United Kingdom

Location

Related Publications (2)

• [1] Conte MS, Bradbury AW, Kolh P, et al. GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. Eur J Vasc Endovasc Surg, 2019. 58: p. 1-109.

  BACKGROUND

• [2] Waton S, Johal A, Li Q, et al. National Vascular Registry: 2023 State of the Nation Report. London: The Royal College of Surgeons of England, November 2023.

  BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Reader Cardiovascular Sciences, Consultant and Clinical Director

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: May 8, 2024
• Study Start: May 28, 2024
• Primary Completion: May 28, 2025
• Study Completion (Estimated): April 28, 2030
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)